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Primary Care Management of Lower Urinary Tract Symptoms in Men (PriMUS)

Primary Purpose

Lower Urinary Tract Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Urodynamics
Sponsored by
Cardiff University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lower Urinary Tract Symptoms focused on measuring Lower Urinary Tract Symptoms, Primary Care, Urology

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Men aged 16 years and over.
  • Men who present to their GP with a complaint of one or more bothersome lower urinary tract symptoms (LUTS)#
  • Men able and willing to give informed consent for participation in study
  • Men able and willing to undergo all index tests and reference test, and complete study documentation.

    • This would include men on current treatment, but who are still symptomatic

Exclusion criteria

  • Men with neurological disease or injury affecting lower urinary tract function
  • Men with LUTS considered secondary to current or past invasive treatment or radiotherapy for pelvic disease
  • Men with other contraindications to urodynamics e.g. Heart valve or joint replacement surgery within the last 3 months, immunocompromised/immunosuppressed.
  • Men with indwelling urinary catheters or who carry out intermittent self-catheterisation
  • Men whose initial assessment suggests that clinical findings are suggestive of possible:

    • prostate or bladder cancer*
    • recurrent or persistent symptomatic UTI**
    • retention e.g. palpable bladder after voiding'
  • Men unable to consent in English or Welsh where a suitable translator is not available. This is a multi-centre study based in primary care, and we cannot guarantee translation facilities at all sites

    • According to standard NHS cancer pathways. If later deemed unlikely, then eligible for study participation.

      • If UTI successfully treated but LUTS remain, then eligible for study

Sites / Locations

  • Cardiff UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Development of Clinical Decision Support Tool

Arm Description

All men will receive the same series of simple index tests which will be compared with the results of the urodynamics reference test to identify which index tests give the best prediction of the urodynamic results. The data from the first cohort will develop the clinical decision support tool.

Outcomes

Primary Outcome Measures

Primary Outcome 1- Sensitivity and specificity of the PriMUS clinical decision aid in diagnosing detrusor underactivity, bladder outlet obstruction and detrusor over activity, in men with lower urinary tract symptoms presenting to primary care.
The accuracy of a clinical decision tool, which incorporates simple index tests, by reference and comparison to Urodynamic investigation as the gold standard at 36 months.

Secondary Outcome Measures

Secondary Outcome 1 - Construction of a patient management algorithm to guide initial treatment for men with LUTS
Identify which combination of simple tests (including e.g. ethnicity, smoking status, height (cm) and weight (kg), medical history, medication, outcome of bladder diary, self-reported symptoms scores using IPSS and ICIQ questionnaires, Digital Rectal Examination Result, Prostate Specific Antigen (PSA) result, Abdominal Physical Examination Result) best predict the urodynamic diagnosis at 36 months.
Secondary Outcome 2 - Qualitative analysis of patients' and clinicians' views on the use of a LUTS decision aid in the primary care setting
Analyse the acceptability of a decision aid in primary care with patients and clinicians, to assess the decision tool's value and potential usability.
Secondary Outcome 3 - Estimate potential percentage change in referral rates to secondary care for men with LUTS
To calculate the potential change in referral rates of men with LUTs into secondary care to calculate the potential overall excess treatment cost savings.
Secondary Outcome 4 - Estimation of potential costs / savings of implementation of the primary care LUTS decision aid both from a population and individual patient perspective
Estimation of potential costs / savings of implementation of the primary care LUTS decision aid both from a population and individual patient perspective

Full Information

First Posted
March 23, 2018
Last Updated
August 10, 2021
Sponsor
Cardiff University
Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust, University of Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03520673
Brief Title
Primary Care Management of Lower Urinary Tract Symptoms in Men
Acronym
PriMUS
Official Title
Primary Care Management of Lower Urinary Tract Symptoms in Men: Development and Validation of a Diagnostic and Clinical Decision Support Tool
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiff University
Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust, University of Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The PriMUS Study aims to develop a clinical decision support tool to help GPs more accurately diagnose and manage LUTS in men. The study will recruit 880 men across three research hubs in Bristol, Newcastle and Wales. Men will all receive a series of simple index tests in primary care (following NICE Clinical Guidelines) and a urodynamics reference test. The study will then compare which combination of the simple index tests give the best prediction of the urodynamics result, which can then be incorporated into the clinical decision support tool.
Detailed Description
Men are more likely to experience bothersome Lower Urinary Tract Symptoms (LUTS) as they get older. GPs follow standard processes to investigate signs of cancer, or more serious conditions but do not have access to tools to identify and manage more common symptoms of LUTS. This means men are likely to be referred to a urologist in secondary care, where they will receive advice or treatment that could have been given in primary care if GPs had more access to better diagnostic tools. The PriMUS Study will compare the results of the simple index tests, with the results of the urodynamic reference test, to identify which combination of simple index tests give the best prediction of the urodynamics diagnosis. The top performing simple index tests will be incorporated into the clinical decision support tool so that GPs can manage patients without needing invasive urodynamics. Follow up will be conducted 6 months post involvement; collating the treatment and management decisions made as a result of these procedures. The study will also consider and explore practicalities and acceptability of the urodynamic procedure and clinical decision support tool for both patients and clinical staff by conducting separate qualitative work.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms
Keywords
Lower Urinary Tract Symptoms, Primary Care, Urology

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Diagnostic Accuracy Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
880 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Development of Clinical Decision Support Tool
Arm Type
Other
Arm Description
All men will receive the same series of simple index tests which will be compared with the results of the urodynamics reference test to identify which index tests give the best prediction of the urodynamic results. The data from the first cohort will develop the clinical decision support tool.
Intervention Type
Diagnostic Test
Intervention Name(s)
Urodynamics
Intervention Description
All the men in the study will receive the urodynamics procedure as a reference test.
Primary Outcome Measure Information:
Title
Primary Outcome 1- Sensitivity and specificity of the PriMUS clinical decision aid in diagnosing detrusor underactivity, bladder outlet obstruction and detrusor over activity, in men with lower urinary tract symptoms presenting to primary care.
Description
The accuracy of a clinical decision tool, which incorporates simple index tests, by reference and comparison to Urodynamic investigation as the gold standard at 36 months.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Secondary Outcome 1 - Construction of a patient management algorithm to guide initial treatment for men with LUTS
Description
Identify which combination of simple tests (including e.g. ethnicity, smoking status, height (cm) and weight (kg), medical history, medication, outcome of bladder diary, self-reported symptoms scores using IPSS and ICIQ questionnaires, Digital Rectal Examination Result, Prostate Specific Antigen (PSA) result, Abdominal Physical Examination Result) best predict the urodynamic diagnosis at 36 months.
Time Frame
36 months
Title
Secondary Outcome 2 - Qualitative analysis of patients' and clinicians' views on the use of a LUTS decision aid in the primary care setting
Description
Analyse the acceptability of a decision aid in primary care with patients and clinicians, to assess the decision tool's value and potential usability.
Time Frame
24 months
Title
Secondary Outcome 3 - Estimate potential percentage change in referral rates to secondary care for men with LUTS
Description
To calculate the potential change in referral rates of men with LUTs into secondary care to calculate the potential overall excess treatment cost savings.
Time Frame
36 months
Title
Secondary Outcome 4 - Estimation of potential costs / savings of implementation of the primary care LUTS decision aid both from a population and individual patient perspective
Description
Estimation of potential costs / savings of implementation of the primary care LUTS decision aid both from a population and individual patient perspective
Time Frame
36 months

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men aged 16 years and over. Men who present to their GP with a complaint of one or more bothersome lower urinary tract symptoms (LUTS)# Men able and willing to give informed consent for participation in study Men able and willing to undergo all index tests and reference test, and complete study documentation. This would include men on current treatment, but who are still symptomatic Exclusion criteria Men with neurological disease or injury affecting lower urinary tract function Men with LUTS considered secondary to current or past invasive treatment or radiotherapy for pelvic disease Men with other contraindications to urodynamics e.g. Heart valve or joint replacement surgery within the last 3 months, immunocompromised/immunosuppressed. Men with indwelling urinary catheters or who carry out intermittent self-catheterisation Men whose initial assessment suggests that clinical findings are suggestive of possible: prostate or bladder cancer* recurrent or persistent symptomatic UTI** retention e.g. palpable bladder after voiding' Men unable to consent in English or Welsh where a suitable translator is not available. This is a multi-centre study based in primary care, and we cannot guarantee translation facilities at all sites According to standard NHS cancer pathways. If later deemed unlikely, then eligible for study participation. If UTI successfully treated but LUTS remain, then eligible for study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bethan Pell
Phone
02922510475
Email
pellb@cardiff.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Emma Thomas-Jones
Email
thomas-jonese@cardiff.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Edwards Profressor
Organizational Affiliation
Division of Population Medicine, Cardiff University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chris Harding Mr
Organizational Affiliation
Newcastle Upon Tyne NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiff University
City
Cardiff
ZIP/Postal Code
CF14 4YS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janine Bates
Email
BatesMJ@cardiff.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

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Primary Care Management of Lower Urinary Tract Symptoms in Men

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